EU Clinical Trials Directive / UK Clinical Trials Regulations
Most clinical research must adhere to the Research Governance Framework for Health and Social Care. Clinical Trials of Investigational Medicinal Products must also adhere to the following:
EU Clinical Trials Directive
The European Clinical Trials Directive 2001/20/EC (EUCTD) was introduced to establish standardisation of research activity in clinical trials throughout the European Community. The EUCTD was transposed into UK law as the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/ 1031) which came into force 1st May 2004.
The European Union Clinical Trials Directive (2001/20/EC) provides a framework which sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. It includes medicinal trials with healthy volunteers and small scale or pilot studies.
The Directive aims are to:
- Provide greater protection to subjects participating in clinical trials
- Ensure quality of conduct
- Harmonise regulation and conduct of clinical trials throughout Europe
EU Good Clinical Practice Directive
Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
The International Conference on Harmonisation Guidance on Good Clinical Practice (Topic E6) (CPMP/ICH/135/95) is an international standard for GCP.
The Good Clinical Practice Directive 2005/28/EC supplements the Clinical Trials Directive, strengthening the legal basis for requiring Member States to comply with the principles and guidelines of good clinical practice, as set out in the ICH-GCP guidelines.
The Medicines for Human Use (Clinical trials) Regulations 2004
The EU Clinical Trials Directive was transposed into UK Law as the Medicines for Human Use (Clinical Trials) Regulations 2004 and came into force on 1st May 2004. The UK Clinical Trials Regulations 2004 include additional controls:
- Establishment of ethics committees on a legal basis
- Each Clinical Trial must have an identified Sponsor who takes responsibility for its initiation, conduct and management
- Phase 1 pharmacology studies in healthy volunteers require authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA)
- Investigational medicinal products (IMPs) must be manufactured to Good Manufacturing Practice (GMP) standards and the manufacturer must have a manufacturing licence
- The MHRA is empowered to carry out statutory inspections of the sponsor, researchers, facilities and manufacturing organisations for GCP, GMP and pharmacovigilance to help ensure required standards are maintained
Failure to comply with the UK Clinical Trials Regulations 2004 can lead to penalties of fines and/or a custodial sentence for non-compliance. A summary of the regulations is available here
Amendments to the Regulations
There have been various amendments to the Medicines for Human Use Clinical Trials Regulations as listed below:
- The Medicines for Human Use (Clinical Trials) Amendment (No.1) Regulations SI (2006/1928)
- The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations SI (2006/2984)
- The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 SI (2008/941)
- The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 SI (2009/1164)
All Clinical Trials of investigational medicinal products (CTIMP) must be conducted within these regulations. A summary of these amendments is available here